Addivation Medical Cervical Interbody Device

GUDID B804AOCS61451

Cervical Spine Interbody Device. 14 x 16mm footprint, 5mm height, 6 degrees lordosis.

ADDIVATION MEDICAL, LLC

Spinal fusion sphere

• Primary Device ID: B804AOCS61451
• NIH Device Record Key: 7267b55f-7e6a-44a7-ad88-dca0a8d27b50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Addivation Medical Cervical Interbody Device
• Version Model Number: AOCS6145
• Company DUNS: 117239290
• Company Name: ADDIVATION MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B804AOCS61451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190291

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

On-Brand Devices [Addivation Medical Cervical Interbody Device]

• B804AOCS61491: Cervical Spine Interbody Device. 14 x 16mm footprint, 9mm height, 6 degrees lordosis.
• B804AOCS61481: Cervical Spine Interbody Device. 14 x 16mm footprint, 8mm height, 6 degrees lordosis.
• B804AOCS61471: Cervical Spine Interbody Device. 14 x 16mm footprint, 7mm height, 6 degrees lordosis.
• B804AOCS61461: Cervical Spine Interbody Device. 14 x 16mm footprint, 6mm height, 6 degrees lordosis.
• B804AOCS61451: Cervical Spine Interbody Device. 14 x 16mm footprint, 5mm height, 6 degrees lordosis.
• B804AOCS61421: Cervical Spine Interbody Device. 14 x 16mm footprint, 12mm height, 6 degrees lordosis.
• B804AOCS61411: Cervical Spine Interbody Device. 14 x 16mm footprint, 11mm height, 6 degrees lordosis.
• B804AOCS61401: Cervical Spine Interbody Device. 14 x 16mm footprint, 10mm height, 6 degrees lordosis.
• B804AOCS61291: Cervical Spine Interbody Device. 12 x 14mm footprint, 9mm height, 6 degrees lordosis.
• B804AOCS61281: Cervical Spine Interbody Device. 12 x 14mm footprint, 8mm height, 6 degrees lordosis.
• B804AOCS61271: Cervical Spine Interbody Device. 12 x 14mm footprint, 7mm height, 6 degrees lordosis.
• B804AOCS61261: Cervical Spine Interbody Device. 12 x 14mm footprint, 6mm height, 6 degrees lordosis.
• B804AOCS61251: Cervical Spine Interbody Device. 12 x 14mm footprint, 5mm height, 6 degrees lordosis.
• B804AOCS61221: Cervical Spine Interbody Device. 12 x 14mm footprint, 12mm height, 6 degrees lordosis.
• B804AOCS61211: Cervical Spine Interbody Device. 12 x 14mm footprint, 11mm height, 6 degrees lordosis.
• B804AOCS61201: Cervical Spine Interbody Device. 12 x 14mm footprint, 10mm height, 6 degrees lordosis.